Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • Secondary Myelodysplastic Syndrome
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To determine the effect of induction chemotherapy (IC) (intensive acute myeloid leukemia [AML]-like therapy), versus less intensive hypomethylating agents (HMA) as initial therapy, on failure-free survival. SECONDARY OBJECTIVES: I. Determine if IC (intensive AML-like therapy) ...

PRIMARY OBJECTIVES: I. To determine the effect of induction chemotherapy (IC) (intensive acute myeloid leukemia [AML]-like therapy), versus less intensive hypomethylating agents (HMA) as initial therapy, on failure-free survival. SECONDARY OBJECTIVES: I. Determine if IC (intensive AML-like therapy) in comparison to HMA as initial therapy, will affect transplantation frequency and quality of life. II. Conduct exploratory analysis of post-HCT outcomes (overall survival, and relapse). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC) for 7 days. Treatment repeats every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive induction-like chemotherapy per standard of care or per experimental protocol. This study does not require a specific chemotherapy regimen for Arm B. After completion of study treatment, patients are followed up for 18 months.

Tracking Information

NCT #
NCT01812252
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Bart L. Scott Fred Hutch/University of Washington Cancer Consortium